october 2016€¦ · numis securities limited ("numis") and stifel nicolaus europe...

www.ergomedplc.com www.ergomedplc.com

TRANSFORMING DRUG DEVELOPMENT

October 2016

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www.ergomedplc.com www.ergomedplc.com www.ergomedplc.com

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Building a profitable services business

combined with

sustainable product development

for significant shareholder value.

OUR MISSION

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Balanced downside protection and upside potential

HYBRID BUSINESS MODEL

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PROFITABLE, FAST GROWING,

PREDICTABLE

BREAK-OUT UPSIDE

POTENTIAL

SERVICES PRODUCTS

Global platform

Full range of services

EBITDA accretive acquisition opportunities

Diversified portfolio

Multiple shots on goal

Managed risk approach


All clinical phases and post-approval

SERVICES – COMPREHENSIVE RANGE

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Clients include biotech, specialty pharma, pharma and generics companies

SERVICES

PRE-APPROVAL DRUG

DEVELOPMENT

POST-APPROVAL

DRUG MARKETING

Phases I – III Phase IV Drug Safety Medical

Information

Project management

Patient recruitment

Medical writing

Data management / statistics

Regulatory affairs

Quality assurance

Adverse event case processing

Medical safety review / reports

Consulting / audit

Medical information

QPPV / Qualified person


Out-pacing the market with global solutions

SERVICES – FAST-GROWING

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* Source: Transparency Market Research

**Source: Global Data

£17.6m

1H16

Revenue

£5.6m

£12.0m

STRONG ORDER BACKLOG OF £60m

+11 % CRO Services Pharmacovigilance

Services +53 %

CRO Services

Industry Growth

+7.5%**

PV Industry Growth

+17%*


Efficient management and control of complex trial protocols

PRE-APPROVAL SERVICES: KEY DIFFERENTIATORS

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ALL CROs

STUDY PHYSICIAN

TEAM

SITE MANAGEMENT

TEAM

PROJECT MANAGER

STUDY MONITOR(S)

HOSPITAL

INVESTIGATOR

NURSES/ SITE STAFF

• Peer-to-peer support

• Develops best practice across treating centres

• Provides expertise for particular study designs

• Enhanced recruitment

• Increased retention

• More evaluable patients


Europe’s leading independent pharmacovigilance business

POST-APPROVAL SERVICES

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High customer retention leads to strong

backlog of contracts

Queens Award for Enterprise in 2014

Recent expansion into the US and further

acquisition plans

230+ employees supporting 60+ customers with

products marketed in 100+ countries


19 year track record of performance and execution

PROFITABLE SERVICES – GLOBAL PLATFORM

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55,000+ adverse event

cases p.a.

£30m+ revenue

50,000+ patients studied

Ergomed Offices Longstanding Partners

350+ employees

300+ studies

100+ active clients

Clinical trials

in 54 countries

Supporting

products in

100+ countries


SHARED

INVESTMENT

Through co-development model

SUSTAINABLE PRODUCT DEVELOPMENT

30-50% reduction in fees

Ergomed investment

$1 to 15m

Ergomed focuses on Clinical

Partner focuses CMC, Pre-

Clinical, Commercialisation

COMPLEMENTARY

ACTIVITY

PROPORTIONATE

UPSIDE

Equity share of company

5-15% share of revenue

or

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Building a portfolio with significant upside potential

OUR DIVERSIFIED PRODUCT PIPELINE

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COMPOUND PARTNER NEXT

MILESTONE

PRE-

CLINICAL PHASE I PHASE II PHASE III

Partnership

AEZS 108 Aeterna

Zentaris 1H 2017

Multikine® Cel-Sci 2018

Lorediplon Ferrer 2H 2016

Sevuparin Dilaforette 2017

Multikine® Cel-Sci TBC

Ownership

PeproStat™ 1H 2018

ReadyFlow™ 2H 2017

Endometrial Cancer

Head & Neck Cancer

Insomnia

Sickle-Cell Disease

Perianal warts

Haemostasis

Haemostasis

Evaluate 100+ deal opportunities per year, aim to sign two per year


Reporting end of 2016 / 1Q17

TWO NEAR TERM VALUE INFLEXION OPPORTUNITIES

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* Analysts’ estimates

patients

sites

countries

Phase II trial of lorediplon

Potentially best in class, long-acting,

less hangover for insomnia

Peak sales potential of $650m*

patients

sites

countries

Phase III trial of Zoptrex™

Potentially first FDA approved medical

therapy for advanced endometrial

cancer

Peak sales potential of $500m*

130

3

11

500

22

115


Global market >$2.5 billion, growing 6% pa

NEW CLASS OF COAGULANT (HAEMOSTAT)

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PATENTED FIBRINOGEN-BINDING

PEPTIDE TECHNOLOGY FOR SURGICAL BLEEDING


$500Million combined sales potential

TWO LEAD PRODUCTS

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PeproStat™

Liquid

Accessible bleeds

Phase IIb ready

ReadyFlow™

Gel

Uneven wounds

Preclinical

1.4 minutes

(PeprostatTM)

3 to 6 minutes

(Thrombin)

1 Faster 1

2 More effective

2

PreproStatTM 2.5mg/ml

Thrombin 1000

Sponge with Saline

Tachosil

3 Ready-to-use

4 Blood-free source

ReadyFlow™

Approx. one year behind PeproStat™

Similar development costs

PRODUCTS ADVANTAGES DEVELOPMENT

PROGRAMME

vs

PeproStat ™

CMC, Phase IIb/III costs £15m

Market launch 2020


Another half-year of strong performance

INTERIM 2016 FINANCIAL HIGHLIGHTS

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• Revenues up 21% to £17.6 million (1H15: £14.5 million)

• Including revenue growth of 53% from PrimeVigilance

• Gross profit up 26% to £5.3 million (1H15: £4.2 million)

• EBITDA (adjusted) up 12% to £1.9 million (1H15: £1.7 million)

• Adjusted for £0.4 million M&A and £0.1 million R&D costs

• Cash and cash equivalents of £9.9 million as at 30 June 2016 (2015: £4.9 million) with zero debt

14.5

17.6

1H15 1H16

Revenue (£m)

1.7 1.9

1H15 1H16

Adj. EBITDA (£m)

+21% +12%


Solid progress

1H 2016 OPERATIONAL HIGHLIGHTS

Acquired Haemostatix, raised £9.2 million in

institutional placing

Acquired O+P and GASD

Opened US PrimeVigilance office in

Boston, MA

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Ergomed completes recruitment of Phase IIa

trial of lorediplon

Co-development partner Aeterna Zentaris

announces two licensing deals

Contract win validates strategic rationale for

German acquisitions

£19m new business signed in 1H16 2016 planned revenue fully contracted


Multiple value inflection opportunities near term

NEWSFLOW

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Co-development deals – target two p.a.

Services acquisitions

PeproStat / ReadyFlow out- licensing opportunities

2017 2018

• Ferrer: Phase II insomnia results • Aeterna Zentaris: Zoptrex™

Phase III results

• Haemostatix: PeproStat™

Phase IIb start

• Dilaforette: Sevuparin

Phase II interim results


Phase IIb results

• Haemostatix: ReadyFlow™

Phase I ready


Phase III ready

• CEL-SCI: Phase III head & neck

cancer results

2H 2016


Profitable Services with break-out potential from Product Portfolio

BUILDING SIGNIFICANT SHAREHOLDER VALUE

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5 Year Shareholder

value drivers

Services:

Stable profitable growth

Products:

Breakout potential

Commitment to remain overall EBITDA positive

E B

I T

D A


QUESTIONS?

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APPENDIX

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100 Reviews

CDA / Due Diligence

Advanced Negotiations

DEALS

50

12

2

Co-development leverages services expertise

STRUCTURED DUE DILIGENCE PROCESS

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Desktop review by BD analysts annually

• Medically led

• Therapeutic expert

reviews

Comprehensive review covering:

• IP

• Legal

• Finance

Deals per year

• Regulation

• Clinical

• CMC

• Confidential package

• Focus on clinical need

• Commercialisation


Strong trading performance

PROFIT AND LOSS ACCOUNT

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£000s FY 2015 FY 2014

REVENUE 30,178 21,155

Cost of sales (21,808) (15,385)

GROSS PROFIT 8,370 5,770

Administrative expenses (5,186) (3,677)

Other operating income 81 54

Amortisation of acquired intangible assets (596) (446)

Share-based payment charge (288) (338)

M&A costs (272) (285)

Exceptional items (37) (299)

OPERATING PROFIT 2,072 779

Finance costs (net) – (2)

PROFIT BEFORE TAXATION 2,072 777

Taxation (520) (199)

PROFIT FOR THE PERIOD 1,552 578

EBITDA (adjusted) 3,382 2,429


Strong working capital, no debt

BALANCE SHEET

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£000s 31 December 2015 31 December 2014

Goodwill 7,488 7,282

Intangibles 2,819 2,927

Other non-current assets 883 547

NON-CURRENT ASSETS 11,190 10,756

Trade and other receivables 9,528 6,343

Cash and cash equivalents 3,974 4,576

CURRENT ASSETS 13,502 10,919

TOTAL ASSETS 24,692 21,675

CURRENT LIABILITIES (7,233) (5,755)

NET CURRENT ASSETS 6,269 5,164

NON-CURRENT LIABILITIES (523) (581)

TOTAL LIABILITIES (7,756) (6,336)

NET ASSETS 16,936 15,339


ERGOMED BOARD

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Dr Miroslav Reljanovic – Founder and Chief Executive Officer

Dr Miroslav Reljanovic is a medical doctor and a board-certified neurologist. Whilst practicing as a physician in a large WHO Collaborating Centre in Zagreb, he was the

clinical investigator in numerous Phase II and III studies in the field of neurology and a consultant to various pharmaceutical companies. In 1997 he founded Ergomed as

a clinical research organization and he introduced the novel Study Site Coordination model as an intrinsic part of the conduct of clinical studies. In 2008, together with

Elliot Brown, he founded PrimeVigilance in 2008, which soon became a leading specialist vendor of contracted pharmacovigilance services to the pharmaceutical industry.

Neil Clark – Chief Executive Officer - PrimeVigilance

Neil Clark joined Ergomed as Chief Financial Officer in January 2009 and was promoted to Chief Executive Officer – PrimeVigilance in January 2016. Prior to joining

Ergomed, Neil was Chief Executive Officer of CeNeS Pharmaceuticals plc, a UK biotech company listed in London. Prior to joining CeNeS, Neil worked for PwC in

Cambridge, UK. Neil is a chartered accountant (FCA).

Andrew Mackie – Chief Business Officer

Andrew Mackie joined Ergomed as Chief Business Officer in 2015 having worked with the company as a consultant since 2004. He has been instrumental in developing

the co-development business and negotiating the partnerships signed to date. Prior to joining Ergomed, Andrew worked in the Business Development group at Eli Lilly,

having previously been Head of Life Sciences at IP Group and Head of Alliance Management at Antisoma. Prior to that, Andrew held a variety of R&D positions at

Novartis, Sanofi and MDS. Andrew holds a BSc in biochemistry from Queen’s University (Canada), an LLB from the University of London and an MBA from the London

Business School.

Stephen Stamp – Chief Financial Officer

Stephen Stamp joined Ergomed as Chief Financial Officer in January 2016. Prior to joining Ergomed, Stephen worked in the US as Chief Financial Officer of AssureRx

Health, Inc,. Prior to that he was CFO of EZCORP, Inc. and Chief Operating Officer and CFO at Xanodyne Pharmaceuticals, Inc. Before leaving for the US, Stephen was

Group Finance Director of Shire plc and Regus Plc. Earlier in his career, Stephen worked for and KPMG in London where he qualified as a Chartered Accountant.

Rolf Stahel – Non-Executive Chairman

Rolf Stahel brings over 30 years’ experience in the global pharmaceutical industry. He led Shire plc as Chief Executive Officer from 1994 to 2003, having previously

worked for 27 years with Wellcome plc in Switzerland, Italy, Thailand, Singapore and the UK. Rolf sits on the Advisory Board of Imperial Business School (Imperial

College London) and is currently Non-Executive Chairman of Connexios Life Sciences and Midatech. Rolf is a graduate in Business Studies (KSL, CH) and attended 97th

AMP (Harvard).

Peter George – Non-Executive Director

Peter has over 20 years’ experience in the pharmaceutical services industry and is currently Chief Executive Officer of Clinigen Group plc (AIM: CLIN). Prior to Clinigen,

he was CEO at Penn Pharma, having led a £67m management company buy-out in 2007. Before this, Peter was executive Vice President for Wolters Kluwer Health with

responsibility for Europe and Asia Pacific regions. Peter has also held senior roles at Unilabs Clinical Trials International and was Head of Clinical Pathology in the Oxford

region of the NHS.

Christopher Collins – Non-Executive Director

Christopher was the CEO and a founding partner of Code Securities, which was formed in 2003 and acquired by Nomura in 2005. Chris was previously head of the Life

Sciences Group at WestLBPanmure, having founded that firm’s activities in the sector in 1993. Prior to WestLBPanmure, Chris was Managing Director of Corporate

Finance at Panmure Gordon, after eight years as a Director of Corporate Finance at Hoare Govett and nine years in corporate finance at Charterhouse Japhet. He has an

MBA and read Biology at Sussex University.


CURRENT FLOWABLES HAVE 8 PREPARATION STEPS

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october 2016€¦ · numis securities limited ("numis") and stifel nicolaus europe...

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